Extension Study for Participants With Advanced Tumors in Pembrolizumab Trials

Phase 1

Conditions: Advanced Tumors
MedDRA version: 20.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-004417-42-ES

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1955

Inclusion Criteria

1. Participants that are currently enrolled in MSD-sponsored pembrolizumab trials and are receiving trial treatment or in a Follow-up Phase at the time KN587 is open. The parent trials must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into KN587.
2. The participant (or legally acceptable representative if applicable) provides informed consent for the trial and agrees to follow study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

There are no exclusion criteria to participate in KN587.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the OS.;Secondary Objective: - To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumab based combination.<br>- To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment.;Primary end point(s): OS is defined as the time from randomization or start of trial treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last follow-up.;Timepoint(s) of evaluation of this end point: No planned interim analyses will be performed. Periodic summaries of study results will be produced. Subjects will be followed until death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response on the parent trial until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment.<br>- DOCR is determined by disease assessment and is defined as the time from the date of CR on the parent trial until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment.<br>- Participants who experience SAEs, AEOSI or ECI.;Timepoint(s) of evaluation of this end point: No planned interim analyses will be performed. Periodic summaries of study results will be produced. Subjects will be followed until death.